FDA Approves Self-administered Flu Vaccine

Written by Mary Talley Bowden MD on August 25, 2025. Posted in Current News

The FDA just approved Astra Zeneca’s needle-free FluMist vaccine for self-administration at home, and the company will start mailing this live vaccine to homes across the country for the 2025-2026 flu season

Though the intranasal flu vaccine has historically accounted for a very small percentage of the total flu vaccine supply (eight percent), FluMist is expected to explode in growth due to its non-invasive nature and now easy access.

Mainstream media is gushing over this new development, flooding the public with free advertising on behalf of Astra Zeneca, and naturally this free marketing is completely void of potential downfalls.

Federal laws require drug companies to present a fair balance of risks and benefits when advertising, including all side effects, but not media companies!

Case in point, this article from NBC news does not mention a single downside to spraying one’s nose with a live virus.

Prior to the pandemic, I was a dutiful recipient of the flu shot and made sure my kids got it too. My compliance however was blind, as I never actually researched the safety or efficacy data of what I was injecting into my body and my kids’ bodies. Never again!

I have since learned the flu shot does not reduce hospitalization or death in the elderly1 2 and can actually increase the risk of contracting other respiratory viruses.3

FluMist is an attenuated live virus, meaning a weakened version of the virus infects the recipient then replicates inside the nose. Presumably this localized infection stimulates the immune system to make antibodies to protect from a systemic infection, but in the package insert, the company admits they don’t fully understand how the vaccine works.

After the virus infects the recipient and starts replicating, it sheds – meaning it’s capable of spreading to other people and infecting them. The table below from the package insert shows shedding can last up to 28 days after receiving the vaccine.

Is this shedding dangerous to others? It must be fine because the company studied 55 adults and 49 children for an entire month, and no one died. This is the kind of flimsy research we thought the new FDA was going to protect us from.

The company claims the vaccine is not absorbed systemically and can be safely used during pregnancy and breastfeeding, with the implication being that drugs sprayed in the nose stay in the nose. I’m betting cocaine enthusiasts would disagree with this premise.

The package insert does not state whether FluMist has been studied in pregnant and breastfeeding women, and I had to dive deeper to find an answer on whether its recommended for these women.

Essentially the CDC recommends the flu shot (inactivated virus) rather than FluMist during pregnancy, but the company omits this from their package insert.

The majority of pharmaceutical products must be tested for potential carcinogenesis, mutagenesis and impairment of fertility but not vaccines, including this one. As we know, vaccines are special.

Post-marketing surveillance is important, but the company states its tricky to gather reliable data. I attempted to look for it on the government’s VAERS site but was overwhelmed by the complexity.

OpenVAERS does a good job of making this data more accessible, and according to them, there have been 10,369 reports following FluMist administration. We can add two zeroes to the end of this number given the known problem with underreporting to VAERS.4

Here are the issues the company admits to, but the absence of numbers makes it impossible to know how frequent or serious these are.

Does FluMist work?

Ideally a flu vaccine should prevent infection AND prevent hospitalization and death, both of which are higher in the very young and the very old. But FluMist is not even approved for those most likely to have complications from the flu – children under two and people over 65.

And for adults 50 – 64 years of age, the company admits FluMist fails to even prevent febrile illness.

The ultimate goal of any vaccine is to reduce hospitalization and death, but Astra Zeneca does not directly share that data. In the package insert (I attempted and failed to find additional data on the FDA’s website), they present studies showing decreased incidence of febrile illness after FluMist in children (not adults) but omit outcomes data beyond that.

However, in a table concerning adverse reactions in young children, the company actually shows their product increases the risk of hospitalization in children under two and does not significantly prevent hospitalizations in children under five.

In adults, the study did not show efficacy in even preventing febrile illness:

“Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50 through 64 years of age. Primary and secondary effectiveness 18 of 20 endpoints from the age group 18 through 49 years are presented in Table 6. Effectiveness was not demonstrated for the primary endpoint in adults 18 through 49 years of age.”

Again, Astra Zeneca does not share data showing prevention of hospitalization or death. FluMist was not studied in high-risk adults, including immunocompromised, and though it was compared with a saline placebo, it has not been studied next to early treatment modalities such as antiviral medications.

The Bottom Line

• FluMist is being heavily marketed as a safe, easy and effective way to protect against the flu, and for the first time ever, Americans will be able to give themselves a flu vaccine in their home.
• FluMist increases the risk of hospitalization in children under 2 and does not prevent hospitalization in children ages 2 – 5. FluMist does not decrease the incidence of febrile illness in adults and is not recommended in adults over 65. I could find no data regarding prevention of hospitalization and death in people older than 5 – presumably it doesn’t exist.
• FluMist is a live, attenuated virus that can shed for at least 28 days and infect those around you. Very little research has been performed to determine if this could have dangerous consequences.
• The safety of FluMist for pregnant and breastfeeding women is unknown. The company says its fine; CDC states otherwise.
• AstraZeneca can’t be bothered to gather and provide accurate post-marketing surveillance data about FluMist.

Personally, I will never again get a flu shot or mist my nose with a live flu virus. I’ll optimize my immune system by keeping my weight where it needs to be, limiting my sugar intake, making sure I’m getting enough vitamin D, and getting enough sleep.

If that fails, early treatment options are available, including ivermectin. Ivermectin is a safe, broad-spectrum antiviral with efficacy against RNA viruses5 that works by inhibiting transportation of viral proteins into the nucleus.

References

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